Yesterday, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, "Menu Labeling: Supplemental Guidance for Industry" (Draft Guidance). In the Draft Guidance, FDA addresses comments it received on the May 2017 interim final rule (IFR) extending the compliance date for the Menu Labeling Final Rule (Menu Labeling Rule or the Rule) from May 5, 2017 to May 7, 2018.

By way of background, the Agency’s Menu Labeling Rule (discussed here, here, and here) requires restaurants and “similar retail food establishments” (e.g., convenience stores and grocery stores) that are part of a chain of 20 or more locations and that sell similar menu items to post on menus and menu boards: (1) calorie information; (2) a statement on suggested daily caloric intake; and (3) a statement that written nutrition information is available upon request (and provide such information upon request).

Recall that in late August 2017, groups representing restaurants, grocery stores, and convenience stores reached an agreement with New York City (the City) to ensure that the City will not enforce its analog of FDA’s Rule against the groups’ members with 20 or more locations nationally until May 7, 2018, the compliance date of the Agency’s Rule (discussed here). The settlement followed an announcement by FDA Commissioner Scott Gottlieb, M.D., that the Agency will be providing “additional, practical guidance” on its Rule by the end of the year. In response, City Health Commissioner Mary Bassett noted that while “[w]e take the FDA at its word,…[s]hould the FDA fail to live up to this commitment, this case remains before the court. The city is prepared to defend its right, independent of FDA action, to enforce its requirements that give New Yorkers the information they need to make informed dietary decisions.” Yesterday’s Draft Guidance fulfills Commissioner Gottlieb’s promise made earlier this year, and suggests the Agency is committed to implementing its Rule in May 2018.

Industry met the Draft Guidance with mixed reactions. The National Restaurant Association (NRA) continues to support the Rule and FDA’s efforts related to the same so that its members can avoid complying with a patchwork of state and local menu labeling requirements. Cicely Simpson, executive vice president of public affairs at NRA said that “[w]e are pleased that the Food and Drug Administration took into account the comments from our industry in their menu labeling supplemental guidance document…[and] will continue to work with the FDA to successfully implement federal menu labeling by May 2018.” On the other hand, Lyle Beckwith, senior vice president of government relations for NACS, The Association for Convenience and Fuel Retailing, observed that “[t]here’s absolutely nothing new” in the Draft Guidance and that the document does not “give flexibility or clear guidance on what you could do in any number of situations.” Beckwith continued that retailers are still concerned about potential consumer law suits related to menu labeling. Like NACS, the Food Marketing Institute (FMI) and the National Grocers Association (NGA) are less than impressed with the Draft Guidance, and vowed to work with Congress to ensure flexibility for their members. Greg Ferrara, Senior Vice President of Government Relations & Public Affairs for NGA, noted that “industry concerns with the underlying rule are too fundamental to be addressed by agency guidance” and that “supermarkets need the flexibility to implement the rule across a multitude of store formats, all of which operate much differently than a chain restaurant.”

A few things to note about the Draft Guidance:

Commissioner Gottlieb, in discussing the Draft Guidance, indicated that some store owners asked the Agency whether certain marketing materials would meet FDA’s definition of a menu that would be required to include calorie information. Gottlieb responded that the new guidance explains that these materials are not considered menus under FDA’s regulation and do not require calorie counts. However, the Draft Guidance indicates that such materials generally would not require calorie declarations (i.e., calorie declarations would be required in certain circumstances). And more importantly, the Agency’s “new” guidance on this issue is fairly similar to what FDA said on the same topic nearly three years ago in the preamble to its Rule. What is still not clear is whether or not marketing material used inside of a covered establishment would be treated as a menu that would need to bear calorie information.

Major pizza chains have been pushing for FDA to allow the posting of calorie information on their websites instead of at each store location, given that the vast majority of their customers order online rather than in-store (as high as 90 percent with most major pizza chains), and in light of the burden of addressing on an in-store menu board the thousands of topping combinations people might want on their pizza. The Agency rejected this approach, noting in the Draft Guidance that, even if covered pizza chains declare calories online, if they also have in-store menu boards they must also provide calorie declarations on those.

The Draft Guidance is quite different from other FDA guidance documents in a few respects. For example, it includes a number of color illustrations that depict how various of the Menu Labeling Rule’s requirements could be implemented, including some examples that are currently in use by covered establishments, a feature rarely (if ever) used in Agency guidance documents. In addition, the Draft Guidance includes softer-than-usual language regarding enforcement, especially in the first year of Rule implementation.

To be sure, there are still many unanswered questions and the burdens on industry to comply with the Rule’s highly nuanced requirements remain. Commissioner Gottlieb seemed to acknowledge as much when he indicated that the Agency welcomes continued feedback from stakeholders, which may help improve the Draft Guidance. As with other Agency guidance documents, the Draft Guidance, when finalized, will merely represent FDA’s current thinking on the Rule but will not bind the Agency. In addition, the Draft Guidance, even if/when finalized, will not in any way change the Rule’s requirements.

Jonathan Havens counsels clients on regulatory, compliance, enforcement, and transactional matters related to products regulated by the U.S. Food and Drug Administration (FDA), the Federal Trade Commission (FTC), and the U.S. Consumer Product Safety Commission (CPSC). Manufacturers, importers, distributors, and retailers of conventional foods, dietary supplements, and beverages seek Jonathan’s counsel on product development, claim substantiation, labeling, promotion, registration, reporting, and recall issues to ensure compliance with FDA and USDA requirements. He also provides advice to chain restaurants and retail food establishments, such as grocery stores and convenience stores, on federal and state labeling requirements and to minimize the risk of litigation.